Welcome TUV Rheinland engineers to our company for ISO13485 quality management system audit.
Quality Management System EN ISO 13485 certification
Implementing and maintaining a robust quality management system (QMS) for your medical devices, products and services provides an indispensable foundation on which to build your business. EN ISO 13485 certification of your QMS demonstrates your commitment to operating at a global standard.
The EN ISO 13485 certification process includes on-site audits to verify the capability and reliability of your quality management system. Our experts assess both the practical application and degree of effectiveness in the areas of design, development, production and customer care.
As a well-respected and globally recognized Notified Body, we hold extensive accreditations and are able to serve you at regional facilities worldwide. Our one-stop-shop portfolio consists of comprehensive services designed to accommodate your unique circumstances and business needs.
Optimize your QMS to the global standard of excellence!
Benefits of EN ISO 13485 certification
Medical devices (including Class I) greatly benefit from a production line with an internationally recognised EN ISO 13485 certified quality management system (QMS). The certification framework provides for more product opportunities and extensive market access approval. Manufacturers and sub-contractors of medical devices can leverage their certified QMS status for a seamless transition into specialised certifications such as TCP, MDR, IVDR, and MDSAP. Start-up businesses benefit from the strong position EN ISO 13485 certification provides for future growth and expansion. Mindful preparation for the audit can also serve as an opportunity for all those in the medical devices industry to further refine QMS processes and workflows.
Four steps to EN ISO 13485 certification:
1.Optional preliminary audit
Voluntary site inspection and quality management documentation review assessing your readiness for full-scale Phase I & II auditings.
2.Audit: Stage I
Certification eligibility is assessed by on-site audit results, quality management documentation analysis and business assessment.
3.Audit: Stage II
On-site evaluation of quality management system for excellence in applied practice and efficiency.
4.Certification
Official confirmation certifies your quality management system’s integrity and compliance with the standards.
First-time applicants benefit significantly from opting to undergo the preliminary audit. The process facilitates timely and effective preparation for the official EN ISO 13485 audit process. You are provided documented results that can be immediately applied for making adjustments in your methods before commencing with the mandatory audits.
Transfer of Certification applications is also being accepted, in addition to applications for Certification Renewal.
Our services are conducted using the four-eyes principle, which mandates the evaluations by the audit team and product experts be followed by an independent review for a final decision.
Post time: Nov-16-2022